Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

NCT02224625 | Completed Phase 3 Results

• 1 other identifier: R13-051
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Grading Scale for Visual Evaluation of Skin Condition

  Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested. Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading

  21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)

Study Arms (5)

2% CHG Cloth

EXPERIMENTAL

Chlorhexidine Gluconate 2%

Drug: 2% CHG Cloth solution

Vehicle Cloth

PLACEBO COMPARATOR

Excipients on cloth

Device: Vehicle Cloth

DynaHex (2% CHG)

ACTIVE COMPARATOR

Chlorhexidine Gluconate 2% solution

Drug: Active Comparator

Saline

SHAM COMPARATOR

0.9% sodium chloride

Other: Saline

Sodium Lauryl Sulfate (SLS)

ACTIVE COMPARATOR

Sodium lauryl sulfate to produce mild irritation as a positive control

Other: SLS

Interventions

2% CHG Cloth solution DRUG

Investigational CHG

Also known as: Chlorhexidine Gluconate

2% CHG Cloth

Vehicle Cloth DEVICE

Excipients from CHG cloth only

Also known as: Control

Vehicle Cloth

Active Comparator DRUG

Active comparator

Also known as: DynaHex-2

DynaHex (2% CHG)

Saline OTHER

Negative control

Saline

SLS OTHER

Provides a slight irritation for a positive control

Also known as: Sodium Lauryl Sulfate

Sodium Lauryl Sulfate (SLS)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Free of skin disorders
• Signed consent

You may not qualify if:

• Allergies to latex
• Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
• severe illness
• Pregnant (females)

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

BioScience Laboratories

Butte, Montana, 59701, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate; Sodium Chloride; Sodium Dodecyl Sulfate

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Dodecanol; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Results Point of Contact

• Title: C Beausoleil
• Organization: Bioscience Labs

cbeausoleil@bioscience.com

406-587-5735

Study Officials

• J Pullman, MD

  BioScience Laboratories

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 25, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 9, 2017
• Results First Posted: May 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)